BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PERI-LOC AND PERI-LOC VLP IMPL

    MDR report key: 12741188 · Received November 2, 2021

    Report

    Report Number
    1020279-2021-07775
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    June 22, 2021
    Report Date
    February 8, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PICTURES PROVIDED WERE REVIEWED AND COULD NOT CONFIRM THE STATED FAILURE MODE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE LITERATURE ARTICLE WAS REVIEWED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE NON-UNION AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED. PER THE COMPLAINT DETAILS, NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS AND/OR SOME POTENTIAL PROBABLE CAUSES THAT COULD CONTRIBUTE TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AS OVERUSE OR EXCESSIVE PRESSURE ON THE JOINT, INJURY, PROCEDURAL/USER ERROR, SURGICAL/POST OPERATIVE COMPLICATIONS, HEALING ISSUES AND/OR PATIENT CONDITION. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4). POSTAL CODE: (B)(6). MEHTA, N., GRAHAM, S., LAL, N., WELLS, L., GIOTAKIS, N., NAYAGAM, S., & NARAYAN, B. (2021). FINE WIRE VERSUS LOCKING PLATE FIXATION OF TYPE C PILON FRACTURES. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, 1-8. DOI: DOI.ORG/10.1007/S00590-021-03048-3.

    Description of Event or Problem · 1

    ON THE LITERATURE ARTICLE NAMED "FINE WIRE VERSUS LOCKING PLATE FIXATION OF TYPE C PILON FRACTURES", THE AUTHORS OF THE STUDY REPORTED THAT, WHEN USING AN ORIF SYSTEM TO TREAT TYPE C PILON FRACTURES, ONE PATIENT EXPERIENCED A NON-UNION REQUIRING AN ADDITIONAL SURGERY INVOLVING A 2 STAGE ANKLE ARTHRODESIS WITH CEF. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638093 UNKN PERI-LOC AND PERI-LOC VLP IMPL PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other